| CATEGORY |
INTERPRETATION |
| A |
Adequate, well-controlled studies in pregnant women have not shown an increased risk
of fetal abnormalities to the fetus in any trimester of pregnancy. |
| B |
Animal studies have revealed no evidence of harm to the fetus,
however,
there are no adequate and well-controlled studies in pregnant women.
OR
Animal studies have shown an adverse effect, but adequate and
well-controlled studies in pregnant women have failed to demonstrate a risk to
the fetus in any trimester. |
| C |
Animal studies have shown an adverse effect and there are no adequate
and well-controlled studies in pregnant women.
OR
No animal studies have been conducted and there are no adequate and
well-controlled studies in pregnant women. |
| D |
Adequate well-controlled or observational studies in pregnant women
have demonstrated a risk to the fetus.
However, the benefits of therapy may
outweigh the potential risk. For example, the drug
may be acceptable if needed in a life-threatening situation or serious disease
for which safer drugs cannot be used or are ineffective. |
| X |
Adequate well-controlled or
observational studies in animals or pregnant women have demonstrated positive
evidence of fetal abnormalities or risks.
The use of the product is contraindicated in women who are
or may become pregnant. |
|
REFERENCES
1.
FDA Consumer magazine Volume 35, Number 3 May-June 2001
2. Physicians Desk Reference 57th ed.
Montvale, NJ: Thomson PDR;
2004: 3539
3. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th
edition,Baltimore, MD:
Williams &
Wilkins,2002.
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Created: 11/27/2002
Updated: 11/30/2003
Updated: 3/14/2004
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